Press Release | Sirnaomics

Sirnaomics and Junshi Biosciences Entered Strategic Collaboration to Conduct Clinical Oncology Studies Combining Tuoyi and RNAi in China and US

2020.01.13

Sirnaomics Inc. (“Sirnaomics”), a leading biopharmaceutical company in discovery and development of RNAi therapeutics against cancer and fibrotic diseases, and Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, and other major diseases, jointly announced today that the two companies have entered a strategic collaboration to conduct clinical studies, using Junshi Biosciences’ anti-PD-1 therapy Tuoyi (toripalimab) and Sirnaomics’ RNAi drug candidate STP705 (cotsiranib), for combination treatment in advanced Melanoma, Squamous cell carcinoma and other agreed clinical applications, with high unmet need in both China and the US.

Patrick Lu, PhD, President and Chief Executive Officer of Sirnaomics, stated, “This collaborative effort between Sirnaomics and Junshi Biosciences will be an ideal example of a combination therapy strategy using a clinical stage siRNA drug candidate together with an approved immune checkpoint antibody drug for the treatment of different types of skin cancers. It represents an important clinical approach for combating these deadly diseases where the silencing of gene targets that reduce T-cell access and activity may augment the activity of immune checkpoint inhibitors in skin cancer.”

Michael Molyneaux, MD, Chief Medical Officer of Sirnaomics, stated, “Sirnaomics is very excited to enter into this collaboration agreement with Junshi Biosciences to potentially bring lifesaving therapies to patients with severe skin cancers. It is well known that, despite recent advances in cancer therapies, melanoma is still a deadly form of skin cancer with high unmet need. Our pre-clinical proof of concept oncology data and clinical studies have consistently demonstrated single agent efficacy with STP705. Our most recent work on the mechanism of action strongly suggests that the use of our lead asset STP705 in combination with antibody therapies could greatly benefit patients with skin conditions. Junshi Biosciences has a very strong track record for innovation and execution in the clinical space and a shared vision of bringing lifesaving therapies to their patients. We believe that combining Sirnaomics novel siRNA technology with Junshi Biosciences’ cutting edge antibody therapies has the potential to significantly improve the current treatment landscape for patients with various types of skin cancers.”

About STP705 (Cotsiranib)

Sirnaomics’ leading product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma and Primary Sclerosing Cholangitis. STP705 has demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.

About Tuoyi (toripalimab)

In December 2018, Junshi Biosciences’ anti-PD-1 therapy Tuoyi (toripalimab) was conditionally granted marketing approval for second line treatment of unresectable local progression or metastatic melanoma by the National Medical Products Administration of China (NMPA). In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The company has conducted or has been ready to conduct 11 Phase II/Phase III pivotal clinical trials of the monotherapy or in combination with standard therapy for advanced melanoma, advanced esophageal cancer, adjuvant treatment of advanced hepatocellular carcinoma, non-small cell lung cancer, advanced nasopharyngeal cancer and urothelial carcinoma. Phase Ia clinical trial in the United States has been completed and Phase Ib is on-going. The Company is expanding its cooperation with more third parties to further explore the various efficacy and safety of toripalimab in combination therapy.

About Sirnaomics, Inc.

Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company’s mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at www.sirnaomics.com.

About Junshi Biosciences

Junshi Biosciences (NEEQ:833330; HKEx:1877) was founded in December 2012 by a team graduated from renowned universities in China and the United States with extensive experience in the industry and international transfer of technology.

Junshi Biosciences is mainly engaged in the research and development of therapeutic antibodies. The company specializes in the R&D and industrialization of innovative monoclonal antibody drugs and other therapeutic proteins (TPs) drugs. With an impressive product pipeline including 18 innovative drugs and 2 biosimilars, Junshi Biosciences is the first Chinese company to achieve marketing approval for anti-PD-1 monoclonal antibody in China. It is also the first company in China to have obtained approval for IND application for anti-PCSK9 mAb and anti-BLyS mAb from NMPA. Its world’s first-in-human anti-BTLA mAb has obtained IND approval from the U.S. FDA for tumor treatment. Junshi Biosciences has more than 1000 employees , in San Francisco and Maryland in the United States, and Shanghai, Suzhou, Beijing and Guangzhou in China. For more information, please visit official website: www.junshipharma.com.

Contact:

Sirnaomics, Inc.

Michael Molyneaux, MD, MBA

Chief Medical Officer

michaelmolyneaux@sirnaomics.com

Westwicke, an ICR Company

Investors:

Stephanie Carrington

Stephanie.Carrington@icrinc.com

+1 646 277 1282

Media:

Mark Corbae